Tiotropium / Respimat One Year Study in COPD. - Full Text View

Purpose

The objective of the study is to evaluate the long-term (one year) efficacy and safety of tiotropium delivered by the Respimat inhaler in patients with COPD. Specifically, the study will examine the effect of treatment on COPD exacerbations.

Condition	Intervention	Phase
Pulmonary Disease, Chronic Obstructive	Device: Respimat Drug: Tiotropium	Phase 3

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Primary Purpose: Treatment
Official Title:	Efficacy {FEV1, COPD Exacerbations & HRQoL} & Safety of 5mcg Tiotropium Respimat in COPD

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Tiotropium bromide

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 337 [ Time Frame: Baseline and Day 337 ]
Trough FEV1 is the mean volume of air that can be forced out in one second after taking a deep breath approximately 24 hours after the last administration of study drug.
Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation [ Time Frame: During actual study treatment period (planned Day 1 to Day 337) ]
Time to first COPD exacerbation (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment). Time is days from start of study treatment to onset of exacerbation.

Secondary Outcome Measures:

Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 29 [ Time Frame: Baseline and Day 29 ]
Trough FEV1 is the mean volume of air that can be forced out in one second after taking a deep breath approximately 24 hours after the last administration of study drug.
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 169 [ Time Frame: Baseline and Day 169 ]
Trough FEV1 is the mean volume of air that can be forced out in one second after taking a deep breath approximately 24 hours after the last administration of study drug.
Number of COPD Exacerbations Per Patient - Exposure Adjusted [ Time Frame: During actual study treatment period (planned Day 1 to Day 337) ]
Number of COPD exacerbations (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient adjusted by length of treatment exposure (i.e. number of exacerbations multiplied by 365.25 and then divided by days of treatment exposure)
Number of COPD Exacerbations Per Patient - naïve Estimate [ Time Frame: During actual study treatment period (planned Day 1 to Day 337) ]
Number of COPD exacerbations (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient not adjusted for treatment exposure (i.e. naïve estimate)
Number of Patients With at Least One COPD Exacerbation [ Time Frame: During actual study treatment period (planned Day 1 to Day 337) ]
Number of patients with at least one COPD exacerbation (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment)
Time to First Hospitalisation for COPD Exacerbation [ Time Frame: During actual study treatment period (planned Day 1 to Day 337) ]
Time to first hospitalisation for COPD exacerbation (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment). Time is days from start of study treatment to onset of exacerbation
Number of Hospitalisations for COPD Exacerbations Per Patient - Exposure Adjusted [ Time Frame: During actual study treatment period (planned Day 1 to Day 337) ]
Number of hospitalisations for COPD exacerbations (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient adjusted by length of treatment exposure (i.e. no. of exacerbations multiplied by 365.25 and then divided by days of treatment exposure)
Number of Hospitalisations for COPD Exacerbations Per Patient - naïve Estimate [ Time Frame: During actual study treatment period (planned Day 1 to Day 337) ]
Number of hospitalisations for COPD exacerbations (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient not adjusted for treatment exposure (i.e. naïve estimate)
Number of Patients With at Least One Hospitalisation for a COPD Exacerbation [ Time Frame: During actual study treatment period (planned Day 1 to Day 337) ]
Number of patients with at least one hospitalisation for a COPD exacerbation (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment)
Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Day 337 [ Time Frame: Baseline and Day 337 ]
The SGRQ total score measures quality of life on a continuous scale ranging from 0=best state to 100=worst state
Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Day 169 [ Time Frame: Baseline and Day 169 ]
The SGRQ total score measures quality of life on a continuous scale ranging from 0=best state to 100=worst state
Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 29 [ Time Frame: Baseline and Day 29 ]
Trough FVC is the mean maximum volume of air that can be forcibly expired from the lungs; measured approximately 24 hours after the last administration of study drug.
Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 169 [ Time Frame: Baseline and Day 169 ]
Trough FVC is the mean maximum volume of air that can be forcibly expired from the lungs; measured approximately 24 hours after the last administration of study drug.
Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 337 [ Time Frame: Baseline and Day 337 ]
Trough FVC is the mean maximum volume of air that can be forcibly expired from the lungs; measured approximately 24 hours after the last administration of study drug.

Enrollment:	3991
Study Start Date:	September 2006
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Tiotropium Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)	Drug: Tiotropium
Placebo Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)	Device: Respimat

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female
At least 40 years old
Smoker or ex-smoker
Smoking history > 10 pack-years
Forced Expiratory Volume in 1 Second (FEV1) < 60% predicted

Exclusion Criteria:

Recent history of myocardial infarction, life-threatening cardiac arrhythmia or hospitalisation for cardiac failure
History of asthma or allergic conditions.
Malignancy requiring treatment within past 5 years
Life-threatening pulmonary obstruction, cystic fibrosis or clinically evident bronchiectasis
Known active tuberculosis
Known hypersensitivity to anticholinergic drugs.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00387088

Show 334 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier:	NCT00387088 History of Changes
Other Study ID Numbers:	205.372, 2006-001009-27
Study First Received:	October 11, 2006
Results First Received:	November 13, 2009
Last Updated:	May 18, 2012
Health Authority:	Australia: Responsilble Ethics Committee Brazil: Ministry of Health Canada: Health Canada - Therapeutic Products Directorate China: Food and Drug Administration Denmark: Danish Medicines Agency Finland: Finnish Medicines Agency France: AFSSAPS Germany: BfArM Bundesinstitut fuer Arzneimittel und Medizinprodukte Great Britain: MHRA Greece: National Organization for Medicines (EOF) National Ethics Committee Hong Kong: Department of Health Hungary: National Institute of Pharmacy, H-1051 Budapest India: Ministry of Health and Family Welfare Ireland: Irish Medicines Board Italy: Comitato Etico dell'Azienda Osp. Universitaria Pisana - PISA Korea, Republic of: Korea Food and Drug Administration (KFDA) Lithuania: State Medicines Control Agency, LT-01132 Vilnius Malaysia: Ministry of Health Mexico: Ministry of Health Netherlands: Central Committee on Research Involving Human Subjects (CCMO) Norway: Norwegian Medicines Agency (Statens Legemiddelverk) Portugal: National Pharmacy and Medicines Institute Singapore: Health Sciences Authority,Ministry of Health Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26 South Africa: Medicines Control Council Spain: Ministry of Health Sweden: The National Board of Health and Welfare Switzerland: Swissmedic, Hallerstrasse 7, 3000 Bern Taiwan: Department of Health, Executive Yuan, Taiwan Turkey: Ministry of Health Central Ethics Committee United States: Food and Drug Administration

Additional relevant MeSH terms:

Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Lung Diseases, Obstructive
Tiotropium
Parasympatholytics
Autonomic Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013